A Study of Dara-RVd and Tec-RVd for Multiple Myeloma

This study is looking at two drug combinations, Dara-RVd (daratumumab, lenalidomide, bortezomib, and dexamethasone) and Tec-RVd (teclistamab, lenalidomide, bortezomib, and dexamethasone), for people newly diagnosed with multiple myeloma (a type of blood cancer). The main goal is to see if Tec-RVd, given after three cycles of Dara-RVd, is a safe treatment. Researchers will also check how well these treatments work by looking for "MRD Negativity" (meaning no signs of cancer cells) after about six months. You might be able to join if you are 18 or older and have newly diagnosed multiple myeloma with measurable disease. The study is currently unclear about its recruitment status and plans to enroll about 65 participants.

Study design
This is a Phase 1/2 study that will alternate 6 cycles of Dara-RVd and Tec-RVd induction therapy. It plans to enroll 65 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures toxicity for up to 4 months and MRD Negativity for up to 6 months.

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NCT07099391

A Study of Dara-RVd and Teclistamab-RVd in People With Multiple Myeloma

Recruiting
PHASE1Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~65 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:Dara-RVdTec-RVd

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase I: Toxicity
Measured over up to 4 months
+1 more outcome measured
Multiple Myeloma
7 sites across 2 states
New York4
New Jersey3
  • Neha Korde, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

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Eligibility criteria

Inclusion

IgG myeloma: Serum monoclonal protein ≥ 1.0 g/dL or urine monoclonal protein ≥ 200 mg/24 hr; or
IgA, IgM, IgD, IgE multiple myeloma: serum M-protein ≥ 0.5 g/dL or urine monoclonal protein ≥ 200 mg/24 hr; or
Light chain multiple myeloma: Involved serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum free kappa/lambda light chain ratio
Measurable plasmacytomas seen on imaging (≥ 1 lesion that has a single diameter ≥ 2 cm). If this is the primary marker of measurable disease, patients will need a biopsy at screening.
Bone marrow plasma cells ≥ 30% as determined by CD138 immunohistochemistry staining. 2. Standard risk multiple myeloma - excluding patients with high risk cytogenetic abnormality (HRCA) according to the IMS/IMWG 2024 Consensus Definition:
  • Phase I: Toxicityup to 4 months

    Evaluate the safety and toxicity of Tec-RVd for Phase I participants by the number of Dose Limiting Toxicities experienced within the DLT window

  • Phase II: MRD Negativityup to 6 months

    The primary endpoint is MRD negativity (MRD-) rate upon completion of 6 cycles of alternating Dara-RVd with Tec-RVd.